Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density (2MD-3H-2B)

This study has been completed.
Sponsor:
Information provided by:
Deltanoid Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00715676
First received: July 14, 2008
Last updated: December 7, 2009
Last verified: December 2009
  Purpose

This study will evaluate the effect of a 1-year administration of the vitamin D analog 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density (BMD), safety, and tolerability.


Condition Intervention Phase
Osteoporosis
Drug: Placebo
Drug: DP001
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Randomized, Placebo-Controlled, Daily-dose, Proof-of-concept Study of a Vitamin D Compound in Postmenopausal Women With Osteopenia

Resource links provided by NLM:


Further study details as provided by Deltanoid Pharmaceuticals:

Primary Outcome Measures:
  • Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Change From Baseline in Serum Calcium Levels at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Bone Markers at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects With at Least 1 Treatment-emergent Adverse Event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 157
Study Start Date: March 2007
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1 Drug: Placebo
oral, once daily
Experimental: Group 2
220 ng
Drug: DP001
oral, once daily
Other Names:
  • 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3
  • 2MD
Experimental: Group 3
440 ng
Drug: DP001
oral, once daily
Other Names:
  • 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3
  • 2MD

Detailed Description:

DP001 is a vitamin D analog that has been shown to stimulate bone formation in pre-clinical studies. In a Phase 1B study of postmenopausal women, an increase in the bone formation marker, osteocalcin, was evident without an increase in serum calcium. The aim of this study is to determine if 1-year administration of DP001 to postmenopausal women with osteopenia results in a significant increase in BMD at doses that are safe and well tolerated.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal female subjects, defined as amenorrheic for at least 5 years
  • Body Mass Index of 18 to 35
  • Osteopenic
  • Generally healthy
  • Informed consent

Exclusion Criteria

  • History or evidence of acute or unstable chronic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases
  • Current or recent treatment with any medications or products affecting vitamin D metabolism, calcium balance, bone turnover, or an investigational drug therapy
  • 12-lead electrocardiogram demonstrating QTc (QT interval corrected for heart rate) >450 milliseconds at screening
  • Abnormal creatinine clearance
  • Elevated urinary calcium levels
  • Vitamin D deficiency
  • Excessive dietary calcium or vitamin D intake
  • Current use of any illicit drug and/or history of alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715676

Locations
United States, California
Boling Clinical Trials
Upland, California, United States, 91786
United States, Indiana
Indiana School of Medicine University Hospital
Indianapolis, Indiana, United States, 46202
United States, Maryland
Bethesda Health Research
Bethesda, Maryland, United States, 20817
United States, Nebraska
Creighton University Bone Metabolism Unit
Omaha, Nebraska, United States, 68131
United States, New Mexico
New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Winthrop University Hospital Bone Mineral Research Center
Mineola, New York, United States, 11501
Helen Hayes Hospital Clinical Research Center
West Haverstraw, New York, United States, 10993
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Wisconsin
University of Wisconsin-Madison Osteoporosis Clinical Research
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Deltanoid Pharmaceuticals
Investigators
Study Director: Wendy A Bedale, Ph.D. Deltanoid Pharmaceuticals
  More Information

Publications:
Responsible Party: Hector F. DeLuca, President and Chief Executive Officer, Deltanoid Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00715676     History of Changes
Other Study ID Numbers: Deltanoid 2MD-3H-2B
Study First Received: July 14, 2008
Results First Received: September 16, 2009
Last Updated: December 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Deltanoid Pharmaceuticals:
Osteoporosis
2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3
Vitamin D
Bone Density Conservation Agents
Bone Regeneration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Dihydroxycholecalciferols
Bone Density Conservation Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014